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Founded in 1980, Amgen (short for Applied Molecular Genetics) is a biotechnology firm focused on developing human therapeutics. As an employer, Amgen has been d
Senior Director, Operational Excellence
Location
United States
Posted
11 days ago
Salary
$199.8K - $270.3K / year
Seniority
Senior
Job Description
Senior Director, Operational Excellence
Amgen
• Lead the strategy, governance, transformation, and execution of continuous improvement initiatives across the Research & Development (R&D) Quality organization • Drive scalable, efficient, compliant, and data-driven processes that enhance quality oversight across GCP, GLP, GVP and research functions • Lead governance frameworks, strategic project management, and Quality support for business development activities • Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy and enterprise priorities • Establish and lead governance processes for the R&D Quality • Drive R&D GXP quality governance models to ensure adequate quality performance and escalation from L2 through L0 • Support Global Quality efforts, representing R&D quality, on quality governance as needed • Drive annual goal setting, portfolio prioritization, budget tracking, and business performance reviews • Identify and lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models • Establish project management standards, tools, and governance for strategic Quality initiatives • Lead a portfolio of enterprise and functional projects ensuring scope, timelines, resources, risks, and deliverables are managed • Represent R&D Quality in acquisition assessments, licensing opportunities, and strategic partnerships • Lead Quality due diligence and execute post-close integration plans for acquired assets • In partnership with Global Development, establish KPIs to measure quality performance, efficiency, risk, and project delivery • Build operational excellence and project management capability through coaching, training, and mentoring • Act as a trusted advisor to senior leaders, bringing insights and thought leadership on operational performance • Demonstrate foresight in identifying emerging challenges and opportunities (“looking around corners”).
Job Requirements
- Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master’s degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor’s degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry
- at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- Strong knowledge of GxP regulations including GCP, GLP, PV, and quality system management
- Demonstrated success leading enterprise transformation, governance and complex integration programs
- Strong executive presence with ability to influence senior stakeholders
- Advanced degree (MBA, MS in Operations/Engineering, or similar)
- Certification in Lean Six Sigma (Black Belt or Master Black Belt)
- Demonstrated expertise in designing and implementing KPIs and performance management frameworks
- Strong financial and business acumen; capable of building business cases and measuring ROI
- High EQ, exceptional communication skills, and experience consulting with senior stakeholders
- Strategic mindset with operational execution capabilities—able to align vision with delivery
- Experience integrating data science, AI, or digital tools in operational settings.
- Comfortable with ambiguity and rapid change; thrives in a matrixed, global organization.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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